RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA device recall Z-2627-2016 · posted 2016-08-23 · Terminated

Recall details

Recalling firm

Merge Healthcare, Inc.

Reason for recall

Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.

Action taken

Merge Healthcare sent an Urgent Medical Device Recall letter dated January 28, 2016, and via email on January 31, 2013, to all affected customers. the letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. If you have any additional questions call Merge Customer Service at (877) 741-5369. For further questions, please call (262) 367-0700.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

25 sites potentially have the affected versions

Distribution

Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.

Date initiated

2016-01-31

Date posted

2016-08-23

Date terminated

2017-02-10

Location

Hartland, WI

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